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US Food and Drug Administration (FDA) - Orthopedic Devices Registration
FDA Registered Orthopedic Devices - Updated May 2006

What Is Medical Device Listing?

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. 		FDA Devices
FDA Devices
FDA Devices
FDA Devices


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Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Registered Establishment Name:  ULM-MEDIZINTECHNIK.
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   EXTRACTOR
Registered Establishment Name:  ULM-MEDIZINTECHNIK.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION APPARATUS
Proprietary Device Name:   TRACTION ACCESSORIES
Registered Establishment Name:  ULM-MEDIZINTECHNIK.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   COMPRESSOR
Proprietary Device Name:   COMPRESSOR
Registered Establishment Name:  ULM-MEDIZINTECHNIK.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   DRIVER
Registered Establishment Name:  ULM-MEDIZINTECHNIK.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ARTHROSCOPIC ACCESSORIES
Proprietary Device Name:   ARTHROSCOPIC ACCESSORIES
Registered Establishment Name:  ULM-MEDIZINTECHNIK.
Classification:   RONGEUR
Generic Device Name:   RONGEURS FOR ORTHOPEDIC USE
Proprietary Device Name:   BONE RONGEUR, VARIOUS TYPES
Registered Establishment Name:  HAR-MED GMBH.
Classification:   SPLINT, TRACTION
Generic Device Name:   TYPES OF TRACTION-SPLINT
Proprietary Device Name:   THE COTTON SPLINT
Registered Establishment Name:  THE COTTON GROUP.
Classification:   REAMER
Generic Device Name:   REAMERS OF VARIOUS SIZES
Proprietary Device Name:   CANNULATED REAMER
Registered Establishment Name:  HIGHLAND MEDICAL,INC..
Classification:   POSITIONER, SOCKET
Generic Device Name:   POSITIONER,SOCKET
Proprietary Device Name:   INSTRUMENT HANDLE
Registered Establishment Name:  HIGHLAND MEDICAL,INC..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   FLEXISCOPE II
Registered Establishment Name:  SCHOELLY IMAGING, INC..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   BURR
Proprietary Device Name:   NES REPROCESSED ORTHOPEDIC BURR
Registered Establishment Name:  NORTHEAST SCIENTIFIC, INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   NES REPROCESSED ORTHOPEDIC DRILL BIT
Registered Establishment Name:  NORTHEAST SCIENTIFIC, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   ORTHOPEDIC NEEDLE HOLDER
Proprietary Device Name:   NES REPROCESSED ORTHOPEDIC NEEDLE HOLDER
Registered Establishment Name:  NORTHEAST SCIENTIFIC, INC..
Classification:   REAMER
Generic Device Name:   ORTHOPEDIC REAMER
Proprietary Device Name:   NES REPROCESSED ORTHOPEDIC REAMER
Registered Establishment Name:  NORTHEAST SCIENTIFIC, INC..
Classification:   RONGEUR
Generic Device Name:   ORTHOPEDIC RONGEUR
Proprietary Device Name:   NES REPROCESSED ORTHOPEDIC RONGEUR
Registered Establishment Name:  NORTHEAST SCIENTIFIC, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   ORTHOPEDIC SURGICAL SCISSORS
Proprietary Device Name:   NES REPROCESSED ORTHOPEDIC SURGICAL SCISSORS
Registered Establishment Name:  NORTHEAST SCIENTIFIC, INC..
Classification:   STAPLE DRIVER
Generic Device Name:   STAPLE DRIVER
Proprietary Device Name:   NES REPROCESSED ORTHOPEDIC, ENDOSCOPIC STAPLE DRIVER
Registered Establishment Name:  NORTHEAST SCIENTIFIC, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   CARPAL TUNNEL BLADE
Proprietary Device Name:   NES REPROCESSED CARPAL TUNNEL BLADE
Registered Establishment Name:  NORTHEAST SCIENTIFIC, INC..
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   MIXING TIPS; MIXING BOWL, DISPOSABLE MIXING WELLS
Proprietary Device Name:   ECECO
Registered Establishment Name:  SHENZHEN ECECO MEDICAL INSTRUMENT CO., LTD..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   IST PEDICLE SCREW SYSTEM
Registered Establishment Name:  INNOVATIVE SPINAL TECHNOLOGIES INC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   PEDICLE SCREW SYSTEM INSTRUMENTS
Proprietary Device Name:   IST PEDICLE SCREW SYSTEM INSTRUMENTS
Registered Establishment Name:  INNOVATIVE SPINAL TECHNOLOGIES INC.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   NON-POWERED ORTHOPEDIC TRACTION BED
Proprietary Device Name:   ZHENGTIAN SELF-GRAVITY TYPE TRACTION BED
Registered Establishment Name:  SHENYANG ZHENGTIAN MEDICAL APPLIANCES CO., LTD.
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   DRILL BIT
Registered Establishment Name:  FLEXISMED SA.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  FLEXISMED SA.
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   DEPTH GAUGE
Registered Establishment Name:  FLEXISMED SA.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  FLEXISMED SA.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL FIXATION SYSTEM
Proprietary Device Name:   GSS PEDICLE SCREW SYSTEM
Registered Establishment Name:  GS MEDICAL CO., LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   GS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  GS MEDICAL CO., LTD..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   SAGGITAL BONE SAW GRAFT CUTTING GUIDES
Proprietary Device Name:   PRECIS/S035; S315; BGV200 (MULTIPLE)
Registered Establishment Name:  C-C MEDICAL DEVICES, INC..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   POSTERIOR LONGITUDINAL LIGAMENT KNIFE
Proprietary Device Name:   PRECIS/PLL
Registered Establishment Name:  C-C MEDICAL DEVICES, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   OPTIUM
Registered Establishment Name:  LIFENET.
Classification:   GONIOMETER WITH ELECTRODES
Generic Device Name:   GONIOMETER WITH ELECTRODES
Proprietary Device Name:   FAB-FUNCTIONAL ASSESSMENT OF BIOMECHANICS
Registered Establishment Name:  BIOSYN SYSTEMS INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SPINAL FIXATION DEVICE
Proprietary Device Name:   SELECTIVE AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
Registered Establishment Name:  MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP.
Classification:   PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   PATELLO-FEMORAL KNEE PROSTHESIS
Proprietary Device Name:   PATELLO-FEMORAL KNEE PROSTHESIS
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   PATELLOFEMOROTIBIAL KNEE PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   ORTHOPEDIC TRACTION MACHINE
Proprietary Device Name:   STORM
Registered Establishment Name:  INTELLIGENT ORTHOPAEDICS LTD.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   REPROCESSED ARTHROSCOPIC ACCESSORIES
Proprietary Device Name:   ACCESSORIES,ARTHROSCOPIC
Registered Establishment Name:  SURETEK MEDICAL.
Classification:   REAMER
Generic Device Name:   REPROCESSED SURGICAL REAMER
Proprietary Device Name:   REAMER
Registered Establishment Name:  SURETEK MEDICAL.

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Last Modified: 29 April 2006
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